Questions & Answers
Applicability of the "Treated Articles Exemption" to Antimicrobial Pesticides
February 2000
EPA recently issued guidance, in Pesticide
Registration Notice 2000-1, concerning its policy with respect to
the applicability of the "treated articles exemption." The Notice discusses
EPA's past and present on how treated articles and substances qualify
for the exemption. It also discusses the distinction between public health
and non-public health antimicrobial claims. The Agency has prepared this
Questions & Answers document to address what may be among the most commonly
asked questions on this subject.
- What do the terms "treated article" and "treated articles
exemption" mean?
- Why is this action necessary and how does it affect me?
- What is the key difference between "antimicrobial" products
and "antibacterial" products?
- What are examples of acceptable claims and/or products
under this exemption?
- What are examples of unacceptable products or claims?
- When should companies begin to comply with this guidance?
- What should a pesticide manufacturer do if a product
cannot qualify for a treated articles exemption?
- To whom should I direct any questions regarding registration
requirements and/or the treated articles exemption, and how can I access
the PR Notice for further information?
1. What do the terms "treated article" and "treated articles
exemption" mean?
As stated in Title 40 of the Code of Federal Regulations, section 152.25(a),
a "treated article" is an article or substance treated with, or containing,
a registered pesticide to protect the integrity of the treated article
or substance itself (examples include paint treated with a pesticide
to protect the paint coating or wood products treated to protect the
wood against insect or fungus infestation).
The basic law that regulates pesticides is the Federal Insecticide,
Fungicide and Rodenticide Act, or FIFRA. Before anyone can sell or distribute
a pesticide in the United States, FIFRA requires that the pesticide
be registered by EPA. Before a pesticide can be registered, the manufacturers
of the pesticide must provide a large number of studies to show that
the pesticide can be used without unreasonable risks to humans or the
environment. The "treated articles exemption" provides an exemption
from FIFRA requirements for qualifying articles or substances treated
with, or containing a registered pesticide if (1) the incorporated pesticide
is registered for use in or on the article or substance itself, and
(2) the sole purpose of the treatment is to protect the article or substance
itself, not to provide additional health benefits.
2. Why is this action necessary and how does it affect
me?
In recent years, the marketplace has experienced a proliferation of
products that are treated with pesticides and bear implied or explicit
public health claims. More products are making claims that a product
has "antibacterial" properties for protection against bacteria, fungi,
and viruses, or making specific claims against pathogenic organisms
that may cause food poisoning, infectious diseases, or respiratory problems.
In an effort to minimize both consumer and industry confusion over what
constitutes a correct and acceptable product claim, EPA, in its Pesticide
Registration (PR) Notice 2000-1, is clarifying its current policy and
offering guidance with respect to the scope of the treated articles
exemption.
3. What is the key difference between "antimicrobial"
products and "antibacterial" products?
In the U.S. consumer market place, the term "antimicrobial" has been
typically associated with the protection of articles, such as tents,
etc., whereas "antibacterial" has been more frequently associated with
products designed to control human pathogenic microorganisms.
4. What are examples of acceptable claims and/or products
under this exemption?
Products making "mold and mildew resistant" and/or "odor resistant"
claims could be considered as qualified or acceptable. Examples of such
claims are "This article has been treated with a fungistatic agent to
protect the product from fungal growth" and "This product has been treated
to resist bacterial odors."
A complete assurance that there is no misleading impression could be
achieved through use of such language as "This product does not protect
users or others against food-borne (or disease-causing) bacteria."
5. What are examples of unacceptable products or claims?
Unacceptable label claims include, but are not limited to, "Antibacterial,"
"Bactericidal," "Germicidal," "Kills pathogenic bacteria," and "Effective
against E. Coli and Staph." Such products would require EPA registration
of the article as a pesticide product, since they make public health
claims.
6. When should companies begin to comply with this guidance?
Because some of the elements of the Agency's guidance may require some
interpretation and application by the regulated community (e.g., pesticide
manufacturers, sellers, and/or distributors), EPA expects that some
companies may need as much as a year to comply with those elements clarified
by the PR Notice. Therefore, the Agency will begin relying on this guidance
for compliance purposes on February 11, 2001. However, the Agency encourages
companies to begin complying with this guidance as soon as possible
before that date.
7. What should a pesticide manufacturer do if a product
cannot qualify for a treated articles exemption?
If EPA determines a product or substance does not qualify for a treated
article exemption, the product must be registered as a pesticide product.
Therefore, the manufacturer must submit to EPA a registration application,
as well as all data supporting the proposed claim(s) under which the
product will be marketed. The product must also meet all other applicable
FIFRA registration requirements as contained in 40 CFR parts 152, 156,
and 158.
It should be noted here that the Agency currently does not have established
protocols for the development of data to support public health treated
article claims. Therefore, acceptable protocols for product testing
reflecting actual use conditions must be submitted by the pesticide
manufacturer for EPA approval prior to the development of these data.
As part of this review process, the Agency will require that these protocols
be independently validated for accuracy and reproducibility. Antimicrobial
treated articles requiring registration must meet the same efficacy
performance standards required for all antimicrobial public health products.
8. To whom should I direct any questions regarding registration
requirements and/or the treated articles exemption, and how can I access
the PR Notice for further information?
For further information, you may contact Debra Edwards of the Antimicrobials
Division of EPA at (703) 308-7891.
By mail:
Antimicrobials Division (7510C)
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
By courier:
Antimicrobials Division (7510C)
U.S. Environmental Protection Agency
Room 300, Crystal Mall 2
1921 Jefferson Davis Hwy
Arlington, VA 22202-4501
The PR Notice may be accessed by visiting EPA's website at http://www.epa.gov/opppmsd1/PR_Notices/index.htm.
For general pesticide information, visit OPP's website.
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